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Suppliers and packagers for TOLTERODINE TARTRATE
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TOLTERODINE TARTRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 213397 | ANDA | Ajanta Pharma USA Inc. | 27241-191-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-05) | 2020-06-25 |
| Ajanta Pharma Ltd | TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 213397 | ANDA | Ajanta Pharma USA Inc. | 27241-191-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-30) | 2020-06-25 |
| Ajanta Pharma Ltd | TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 213397 | ANDA | Ajanta Pharma USA Inc. | 27241-191-90 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-90) | 2020-06-25 |
| Ajanta Pharma Ltd | TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 213397 | ANDA | Ajanta Pharma USA Inc. | 27241-192-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-05) | 2020-06-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Tolterodine Tartrate (API and Finished Dosage Forms): Who Makes It, Where It Is Sold, and What to Check on Regulatory Listings
Tolterodine tartrate is an established small-molecule antimuscarinic used for overactive bladder. Supply chains typically split between (1) API manufacturers and (2) contract manufacturers/formulators for tablet and extended-release (ER) products. To identify the actual supplier set for a specific market and strength, buyers should anchor on FDA drug listings (Orange Book), ANDA approvals, and global API/finished-dose regulatory dossiers.
Which companies supply tolterodine tartrate API?
The tolterodine tartrate API supplier universe is usually determined by: (1) who files Drug Master Files (DMFs), (2) who holds ANDA API manufacturing responsibility for specific NDCs, and (3) who supplies branded products directly. In practice, procurement teams map suppliers by matching API DMF holders and ANDA manufacturing sites to Orange Book drug products and then validating via quality audits.
API supply model for tolterodine tartrate
- DMF-based supply: API is manufactured under a DMF, then referenced by multiple ANDAs.
- Route-specific cost drivers: tolterodine tartrate manufacturing includes salt formation and polymorph/process controls that can narrow eligible suppliers.
- Quality package expectations: buyers typically require CoA traceability, validated impurity profiles, and residual solvent control reports aligned with drug substance specifications.
What to pull in supplier due diligence
- DMF holder name and manufacturing site(s)
- Confirmation the DMF covers tolterodine tartrate salt (not only tolterodine free base)
- Impurity specification alignment for planned dosage strengths
- Evidence of commercial scale batches and change control history
What patents protect tolterodine tartrate, and who are likely contract suppliers?
Tolterodine tartrate is off-patent in most major jurisdictions for first-in-class compositions. The current supplier landscape is driven less by composition-of-matter exclusivity and more by:
- formulation and release-mechanism improvements for ER products,
- process patents for specific impurity control or salt/crystal forms, and
- regulatory and quality differentiation rather than exclusivity.
Why patent status affects supply
Even if composition patents have expired, some manufacturers may maintain proprietary:
- tablet compression/formulation approaches,
- ER matrix/coating systems that control release kinetics,
- manufacturing process steps that reduce specific impurities.
What is the Orange Book status of tolterodine tartrate products?
Featured snippet answer: The FDA Orange Book lists approved tolterodine tartrate drug products and related patents (if any) tied to those products. Orange Book listings also provide a practical map to which firms are actively marketing and which ANDA filers are in-market for specific dosage forms and release types.
Orange Book mapping approach (procurement-relevant)
- Identify the exact dosage form and release type:
- immediate-release tolterodine tartrate tablets
- ER tolterodine tartrate capsules or tablets (depending on brand/ANDA)
- Pull the Orange Book entries by NDC and strength
- Capture:
- applicant/manufacturer
- dosage form
- listed patents (if any still active)
- Use ANDA applicants to find likely API and contract manufacturing suppliers via:
- label manufacturing sites (when shown)
- DMF references in ANDA supplements (when publicly traceable)
Who supplies tolterodine tartrate immediate-release tablets (API-to-tablet mapping)?
Immediate-release supply is typically broader because formulation constraints are lower than ER. Procurement shortlists often include:
- DMF-referencing ANDA filers
- multiple contract manufacturers capable of tablet compression and standard excipient systems
- companies with established impurity control for tolterodine tartrate
Key differentiation points
- impurity profile control (process dependent)
- particle size and flow properties for tablet uniformity
- salt hydration and stability data supporting shelf life
Who supplies tolterodine tartrate ER products (and how does formulation change supplier selection)?
ER tolterodine tartrate products typically narrow the supplier pool because the release mechanism requires:
- validated coating or matrix technology,
- narrow dissolution acceptance criteria,
- robustness to scale-up changes.
What ER buyers should verify
- dissolution profile comparability and transferability across manufacturing sites
- specific excipient grades and sourcing controls
- coating/matrix process controls and in-process testing strategy
What generic entry risks exist for tolterodine tartrate suppliers?
The competitive supply risk is rarely about “can we make it.” It is usually about:
- maintaining consistent dissolution and impurity profiles across batches,
- meeting bioequivalence requirements for the ER product if a dosage form changes,
- regulatory backstops (consistency, stability, and inspection readiness).
Common execution risks
- source variability of API (salt form, polymorph, crystal size)
- drift in impurity profile due to upstream process changes
- scale-up differences affecting dissolution for ER
Which FDA pathways and ANDA filings affect tolterodine tartrate supply?
Supply availability in the US is driven by:
- ANDA approvals for generics
- labeling supplements (strength additions, manufacturing site changes)
- quality-related supplements and post-approval manufacturing changes
How buyers link filings to suppliers
- ANDA applicant name is a starting point for finished-dose manufacturer
- NDC label information can identify the firm responsible for finished product release
- API DMF linkage is the best path to name true API suppliers, then confirm at qualification
What manufacturing/IP barriers affect tolterodine tartrate API and product suppliers?
Barrier types that limit eligible suppliers:
- validated salt formation process and crystallization controls
- impurity control with justified limits and analytical method robustness
- inspection history and remediation status
- site capacity and ability to supply required batch sizes with consistent quality
Data room items procurement should request
- DMF letter of authorization or equivalent proof of reference
- CoA history for at least 6 to 12 commercial-scale batches
- stability data showing maintenance of key quality attributes
- change control summary for the last 3 years
How to shortlist tolterodine tartrate suppliers by market: US vs EU vs other regions?
Supplier lists differ by jurisdiction because regulatory approvals are local and manufacturing sites may be region-specific.
US-focused mapping
- Use FDA Orange Book for product-level suppliers and associated patents
- Use ANDA labels for finished-dose manufacturer and packager info
- Use DMF references (where publicly traceable) to identify API producers
EU-focused mapping
- Use EMA product information and national authorizations
- Cross-check API source statements in regulatory filings and inspection reports
Supplier comparison table: what procurement should score
Below is the scoring framework procurement teams should use when comparing tolterodine tartrate API or finished-dose suppliers. It is structured to reflect real qualification gates.
| Supplier type | Verification target | Buyer scoring criteria | Typical contract clause trigger |
|---|---|---|---|
| Tolterodine tartrate API DMF holder | Salt form and impurity profile | impurity trend consistency, method transfer readiness, stability adherence | process change notification and CoA batch analytics |
| Contract finished-dose manufacturer | Tablet/ER performance | dissolution, hardness/friability, uniformity, release consistency | tighter batch release testing and stability commitments |
| ANDA applicant marketing firm | Ongoing regulatory readiness | inspection outcomes, post-approval change performance | supply continuity and audit rights |
Key Takeaways
- Tolterodine tartrate supply is best mapped by Orange Book and ANDA-linked product dossiers, then traced to API DMF references to identify true API suppliers.
- Immediate-release supply is broader; ER product supply is more constrained by release-mechanism formulation and dissolution acceptance.
- Supplier qualification risk centers on API salt form and impurity control, and for ER on dissolution robustness and scale-up consistency.
- Procurement shortlists should score suppliers on commercial batch consistency, stability, inspection readiness, and change control discipline.
FAQs
Which company makes tolterodine tartrate API for generic tablets in the US?
The practical answer is the API DMF holder(s) referenced by US ANDAs for the specific strength and dosage form. Orange Book and ANDA-related labeling references are the fastest route to identify the marketing firm, then link to DMFs for API producer identification.
Who supplies tolterodine tartrate extended-release products?
ER supply is typically handled by manufacturers with established ER formulation platforms. In the US, the supplier set is identified via Orange Book entries for ER NDCs and the ANDA applicant/manufacturer listed on product labeling.
How many DMFs exist for tolterodine tartrate?
The number depends on the DMF holders active across different filing eras and revisions. The definitive count is obtained by screening publicly traceable DMF references tied to current ANDAs for tolterodine tartrate.
What quality attributes matter most for tolterodine tartrate API?
Salt form/crystal characteristics, impurity profile (including process-related impurities), residual solvents, and stability-indicating methods are the core attributes that most affect downstream tablet/ER performance.
What should a buyer ask a tolterodine tartrate API supplier before qualification?
Demand CoA history for commercial batches, stability data, salt form/process description, impurity specifications, and audit-ready documentation for inspection compliance and change control governance.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
- FDA. Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
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